On September 2, 2016, Food and Drug Administration (FDA) issued a new rule prohibiting the use of certain popular ingredients in over‑the-counter (OTC) antiseptic wash products designed to be used with water, such as antibacterial soaps and body washes. The new rule will take effect in approximately one year. FDA also deferred ruling on the use of certain ingredients in these products, to allow for submission of more testing and data. Below are the key highlights and follow-up on FDA's final rule.
What You Need to Know
The FDA's final rule represents a finding that these 19 active ingredients are not generally recognized as safe and effective (GRAS/GRAE) for use in OTC consumer antiseptic wash products and are therefore misbranded in the absence of an approved new drug application. The final rule will prohibit the use of 19 active ingredients in OTC wash products, including the two most commonly used ingredients: triclosan and triclocarban. See below for the full ingredient list.
The new rule will take effect on September 6, 2017, finalizing the FDA's December 2013 proposed rule and amending the 1994 tentative final monograph for OTC antiseptic drug products that was published in June 1994. FDA is deferring its ruling for one year on three other active ingredients: benzalkonium chloride, benzethonium chloride, and chloroxylenol. FDA will accept additional safety and effectiveness data for these ingredients.
The ruling applies to OTC consumer antiseptic wash products, which are intended for use with water and are rinsed off after use (e.g., hand and body washes). In separate rulemakings, FDA is evaluating: (1) OTC consumer antiseptic rubs (products not rinsed off after use, such as hand rubs and antibacterial wipes); and (2) OTC antiseptics intended for use by health care professionals inside or outside of hospitals. Accordingly, these products are not impacted by this final rule, nor are first aid antiseptics or antiseptics used in the food industry.
What You Can Do
Full List of Newly Prohibited Ingredients
Ingredients on Which FDA Has Deferred Action